- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
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Inactive ingredients
Aqua (water), steareth-2, steareth-21, ppg-15 stearyl ether, cyclopentasiloxane, parfum (fragrance), cyclohexasiloxane, dicaprylyl carbonate, triclosan, bisabolol, benzalkonium chloride, methylparaben, tetrasodium edta, aloe barbadensis leaf juice, polyvinyl alcohol, bht, , menthyl pca, , menthol, dipropylene glycol, saccharomyces/sea salt ferment, zea mays (corn) starch, hydrolyzed corn starch, hydrolyzed corn starch octenylsuccinate, acrylates / c12-22 alkyl methacrylate copolymer, citrus medica limonum peel extract (citrus medica limonum (lemon) peel extract), cymbopogon citratus extract, cinnamomun zeylanicum bark extract, lavandula angustifolia flower extract (lavandula angustifolia (lavender) flower extract), mentha piperita leaf extract(mentha piperita (peppermint) leaf extract), olea europaea leaf extract (olea europaea (olive) leaf extract), origanum vulgare leaf extract, rosmarinus officinalis leaf extract (rosmarinus officinalis (rosemary) leaf extract), hydrastis canadensis root extract (hydrastis canadensis (golden seal) root extract), thymus vulgaris extract (thymus vulgaris (thyme) extract), melaleuca alternifolia leaf (melaleuca alternifolia (tea tree) leaf).
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- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label
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INGREDIENTS AND APPEARANCE
CYZONE TRAX COOLTURE DERMO COOL
aluminum sesquichlorohydrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-401 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aluminum sesquichlorohydrate (UNII: UCN889409V) (Aluminum Cation - UNII:3XHB1D032B) Aluminum sesquichlorohydrate 10 g in 50 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) steareth-2 (UNII: V56DFE46J5) steareth-21 (UNII: 53J3F32P58) cyclomethicone 5 (UNII: 0THT5PCI0R) cyclomethicone 6 (UNII: XHK3U310BA) dicaprylyl carbonate (UNII: 609A3V1SUA) triclosan (UNII: 4NM5039Y5X) levomenol (UNII: 24WE03BX2T) benzalkonium chloride (UNII: F5UM2KM3W7) methylparaben (UNII: A2I8C7HI9T) edetate sodium (UNII: MP1J8420LU) aloe vera leaf (UNII: ZY81Z83H0X) polyvinyl alcohol (UNII: 532B59J990) butylated hydroxytoluene (UNII: 1P9D0Z171K) menthol (UNII: L7T10EIP3A) dipropylene glycol (UNII: E107L85C40) starch, corn (UNII: O8232NY3SJ) lemon (UNII: 24RS0A988O) west indian lemongrass oil (UNII: 5BIA40E9ED) cinnamon (UNII: 5S29HWU6QB) lavender oil (UNII: ZBP1YXW0H8) peppermint oil (UNII: AV092KU4JH) olive oil (UNII: 6UYK2W1W1E) oregano (UNII: 0E5AT8T16U) rosemary oil (UNII: 8LGU7VM393) goldenseal (UNII: ZW3Z11D0JV) thyme oil (UNII: 2UK410MY6B) tea tree oil (UNII: VIF565UC2G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-401-60 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part350 08/15/2010 Labeler - VENTURA CORPORATION LTDA. (602751344)